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WO2005096998A1 - Endoprothese encapsulee avec fixation entre couches de greffon - Google Patents

Endoprothese encapsulee avec fixation entre couches de greffon Download PDF

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Publication number
WO2005096998A1
WO2005096998A1 PCT/US2005/009757 US2005009757W WO2005096998A1 WO 2005096998 A1 WO2005096998 A1 WO 2005096998A1 US 2005009757 W US2005009757 W US 2005009757W WO 2005096998 A1 WO2005096998 A1 WO 2005096998A1
Authority
WO
WIPO (PCT)
Prior art keywords
graft
stent
size
assembly according
unattached
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/009757
Other languages
English (en)
Inventor
James B. Hunt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cook Inc
Original Assignee
Cook Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cook Inc filed Critical Cook Inc
Priority to AT05729299T priority Critical patent/ATE464859T1/de
Priority to AU2005231149A priority patent/AU2005231149B2/en
Priority to DE602005020760T priority patent/DE602005020760D1/de
Priority to CA2561498A priority patent/CA2561498C/fr
Priority to EP05729299A priority patent/EP1734899B1/fr
Publication of WO2005096998A1 publication Critical patent/WO2005096998A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching

Definitions

  • the present invention relates generally to medical devices and particularly to a stent assembly with graft layers disposed along luminal and abluminal surfaces of a stent.
  • stent-graft assemblies may be used to treat a number of medical conditions
  • one common use of stent-graft assemblies relates to the treatment of aneurysms.
  • an aneurysm is an abnormal widening or ballooning of a portion of an artery. Generally, this condition is caused by a weakness in the blood vessel wall. High blood pressure and atherosclerotic disease may also contribute to the formation of aneurysms.
  • aneurysms It is possible for aneurysms to form in blood vessels throughout the vasculature.
  • common types of aneurysms include aortic aneurysms, cerebral aneurysms, popliteal artery aneurysms, mesenteric artery aneurysms, and splenic artery aneurysms.
  • an aneurysm may eventually rupture, resulting in internal hemorrhaging.
  • the internal bleeding is so massive that a patient can die within minutes of an aneurysm rupture.
  • the survival rate after a rupture can be as low as 20%.
  • aneurysms have been treated with surgery.
  • abdominal aortic aneurysm the abdomen is opened surgically and the widened section of the aorta is removed. The remaining ends of the aorta are then surgically reconnected.
  • the surgeon may choose to replace the excised section of the aorta with a graft material such as Dacron, instead of directly reconnecting the two ends of the blood vessel together.
  • the surgeon may put a clip on the blood vessel at the neck of the aneurysm between the aneurysm and the primary passageway of the vessel. The clip then prevents blood flow from the vessel from entering the aneurysm.
  • An alternative to traditional surgery is endovascular treatment of the blood vessel with a stent-graft.
  • This alternative involves implanting a stent- graft in the blood vessel across the aneurysm using conventional catheter- based placement techniques.
  • the stent-graft treats the aneurysm by sealing the wall of the blood vessel with a generally impermeable graft material.
  • the aneurysm is sealed off and the blood flow is kept within the primary passageway of the blood vessel.
  • treatments using stent-grafts are becoming preferred since the procedure results in less trauma and a faster recuperation.
  • stent-grafts are frequently used for treating aneurysms, other medical treatments also use stent-grafts and still other uses are being explored. Additional applications for stent-grafts may also be developed in the future.
  • One example of other uses for stent-grafts is the surgical use of stent-grafts as artificial or replacement vessels.
  • stent-grafts may be used to replace excised sections of diseased arteries with an artificial replacement vessel. Usually, this would be performed surgically by connecting the ends of the stent-graft to the ends of the artery remaining in the patient's body.
  • the stent- graft acts like a blood vessel by directing blood flow through the lumen of the stent-graft and preventing blood flow through the walls of the stent-graft.
  • Stent-grafts may be used in still other applications as well.
  • stent-grafts may be used to treat stenosed arteries or other vascular conditions.
  • Stent-grafts may also be used to treat a variety of non-vascular organs, such as the esophagus, trachea, colon, biliary tract, urinary tract, prostate and the brain.
  • One type of stent-graft currently known in the art is constructed with a stent disposed between inner and outer layers of graft material.
  • the graft layers In order to maintain the integrity of the stent-graft assembly during use, the graft layers must be secured to the stent in some manner.
  • Various techniques for securing graft layers to a stent are currently known. However, the known conventional techniques have numerous problems associated therewith, and an improved manner of securing graft layers to a stent is desired.
  • One technique for securing graft layers to a stent generally involves adhering the graft layers directly to the stent itself.
  • stent-grafts made by suturing the graft layers to the stent lose much of the flexibility inherent in the stent itself. This is generally caused by the direct attachment of the graft layers to the stent structure, which forces the entire assembly (i.e., both the graft layers and the stent) to move simultaneously together. As a result, the graft layers restrict the movement of the stent structure. Flexibility of the assembled stent-graft is important for several reasons. For example, radial flexibility is important to allow the stent- graft to be collapsed onto a delivery system while also allowing the stent-graft to expand at the site of implantation.
  • Axial flexibility is also important to enable the stent-graft to bend as it is guided through tortuous pathways to reach the site of implantation. Even after implantation, axial and radial flexibility remain important when the stent-graft is implanted in an area of the body that is expected to experience frequent movement. However, despite the importance of flexibility, stent-grafts that secure the graft layers directly to the stent are relatively inflexible compared to other types of stents. [0010] Another technique that is used for securing graft layers to a stent generally involves encapsulating the stent or a portion thereof with an inner and an outer layer of graft material.
  • the two layers of graft material are adhered to each other through open areas in the stent structure. Some additional bounding may also occur between each graft layer and the stent structure itself. Typically, the inner and outer graft layers are adhered by heating the graft layers or with adhesives.
  • this type of stent-graft also lacks flexibility as described above. This is due in general to the encapsulated construction of these stent-grafts. In particular, the areas in which the two graft layers are attached abut against the structure of the stent, thereby forcing the graft layers to move together with the stent. This causes the graft layers to restrict the movement of the stent structure.
  • a stent-graft assembly is provided with an inner layer of graft material and an outer layer of graft material secured to a stent.
  • the graft layers are secured to each other through openings in the stent structure. Unattached margin areas are further provided between the attached areas of the graft layers and the edges of the openings.
  • Figure 1 is a top plan view of a portion of one embodiment of a stent-graft assembly
  • Figure 2 is a cross sectional view of the stent-graft assembly; and Figure 3 is a top plan view of a portion of another embodiment of a stent-graft assembly.
  • the stent-graft 10 includes a stent 12 with an inner layer 18 of graft material disposed along the luminal surface of the stent 12 and an outer layer 20 of graft material disposed along the abluminal surfaces of the stent 12. As shown in the figures, it is preferable for the graft layers 18, 20 to cover the entire luminal and abluminal surfaces. However, it is also possible for the graft layers 18, 20 to cover only a portion of the stent 12. [0015] Various types of stents 12 may be used with the invention.
  • stents may be made from numerous metals and alloys, including stainless steel, n ⁇ tinol, cobalt-chrome alloys, amorphous metals, tantalum, platinum, gold and titanium. Stents may also be made from non-metallic materials, such as thermoplastics and other polymers.
  • the structure of the stent may also be formed in a variety of ways to provide a suitable intraluminal support structure.
  • stents may be made from a woven wire structure, a laser-cut cannula, individual interconnected rings, or any other type of stent structure that is known in the art.
  • the stent Regardless of the particular construction of the stent, it is usually desirable for the stent to be flexible in several directions, including both radial and axial flexibility. Stents may also be designed to be either balloon-expandable or self-expandable, depending on the particular application of the stent.
  • most stents are formed of a support structure having a plurality of radial openings that extend through the structure between the luminal surface of the stent and the abluminal surface of the stent.
  • the support structure of the stent 12 may be a pattern of interconnected struts 14.
  • the edges of the struts 14 define a series of open areas 16 that extend radially through the support structure.
  • the arrangement, shape and size of the open areas 16 may vary depending on the geometry of the support structure that is used, and the open areas 16 which are shown are only one example of the many possibilities.
  • graft materials may also be used for the inner and outer graft layers 18, 20.
  • graft materials currently used include expandable polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), Dacron, polyester, fabrics and collagen.
  • ePTFE expandable polytetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • Dacron polytetrafluoroethylene
  • graft materials may be made from numerous other materials as well, including both synthetic polymers and natural tissues.
  • One graft material that holds particular promise in certain applications is small intestine submucosa (SIS).
  • SIS material includes growth factors that encourage cell migration within the graft material, which eventually results in the migrated cells replacing the graft material with organized tissues.
  • the graft layers 18, 20 may be formed using a variety of techniques already known to the art.
  • sheets of graft material may be rolled into tubes with the side edges secured together.
  • Unitary tubes may also be formed using a mandrel or the like, which are then coaxially inserted into or drawn over the stent 12.
  • the graft layers 18, 20 may also be formed directly within and on the stent 12. In certain applications, it may also be helpful to impregnate or coat the graft layers 18, 20 with various therapeutic drugs that are well-known to those in the art.
  • the inner graft layer 18 and the outer graft layer 20 are secured together through the open areas 16. Several methods of securing together the graft layers 18, 20 are possible, depending on the particular needs of the application.
  • sutures made from polypropylene thread or other types of thread may be used to sew the inner and outer layers 18, 20 together.
  • the use of sutures for securing graft material to a stent is generally known, but so far this technique has been limited to securing graft materials directly to a stent.
  • One disadvantage that is sometimes experienced with current suturing techniques is the formation of endoleaks through the needle holes that are created in the graft material.
  • Other examples of methods for securing together the inner and outer graft layers 18, 20 include thermal bonding, such as welding or sintering, and the use of adhesives.
  • the area of attachment 22 between the inner and outer layers 18, 20 is smaller than the entire open area 16 through which the layers 18, 20 are attached.
  • the unattached margins 24 are formed between each of the attached areas 22 and the edges of the open areas 16 (i.e., the edges of the struts 14).
  • the unattached margins 24 are areas where the inner and outer layers 18, 20 are not secured together.
  • the unattached margins 24 may be located either axially or circumferentially between the attached areas 22 and the struts 14.
  • the unattached margins 24 are particularly important because the unattached margins 24 allow the inner and outer graft layers 18, 20 to move relative to the stent 12. For example, where the unattached margins 24 are arranged along the same direction as shown, the struts 14 of the stent 12 can move between the graft layers 18, 20 through the unattached margins 14. This results in a stent-graft assembly 10 that is more flexible than current stent-grafts which either secure the graft layers to the stent struts or encapsulate the stent in graft material.
  • the unattached margins 24 are located peripherally all around each of attached areas 22, including both axially and circumferentially between the attached areas 22 and the struts 14.
  • the graft layers 18, 20 may move forward and rearward, side-to-side, and any other direction relative to the stent 12.
  • the site of the attached areas 22 is less than the size of the unattached margins 24.
  • the attached areas 22 may be positioned to restrict relative movement in one direction between the graft layers 18, 20 and the stent 12 while allowing movement in another direction.
  • One such configuration may involve positioning at least some of the attached areas 22 adjacent struts 14 extending in one direction while providing unattached margins 24 between the attached areas 22 and struts 14 extending in another direction.
  • attached areas 22 are positioned adjacent opposite sides of a longitudinally extending strut 14, relative movement between the graft layers 18, 20 and the stent 12 will be restricted in the circumferential direction.
  • the attached areas 22 between the graft layers 18, 20 may be less crucial compared to when the graft layers are secured directly to stent struts.
  • the labor required may be less than traditional suturing techniques.
  • the labor required to secure the graft layers 18, 20 may be reduced even further if thermal bonding is used to secure together the graft layers 18, 20.
  • the two graft layers 18, 20 may be secured together simply by welding the layers 18, 20 together through the open areas 16 without the need for sutures.
  • the stent-graft assembly 10 is also more flexible than stent-graft assemblies with graft layers secured directly to the stent structure or stent- graft assemblies with graft material encapsulated onto the stent structure.
  • Previous methods of securing graft materials to a stent structure restrict the movement of the graft material relative to the stent.
  • conventional stent- graft assemblies are considerably less flexible than the underlying stents themselves.
  • the invented stent-graft 10 solves this problem by providing unattached margins 24 between the attached areas 22 of the graft layers 18, 20 and the edges of the open areas 16.
  • the graft layers 18, 20 and the stent 12 to move relative to each other during flexure by permitting the stent structure to move through the unattached margins 24.
  • the maximum amount of flexibility is possible when unattached margins 24 are provided all around the attached areas 22.
  • the finished stent-graft assembly 10 may be freely flexed in various ways, including angular bending, radial expansion-compression, and even twisting. Other configurations are also possible, however.
  • the effectiveness and simplicity of this approach to the problem of flexibility in stent-grafts makes this solution especially desirable.
  • the invented stent-graft 10 may also be particularly useful in certain applications, although the concepts taught herein have broad applicability.
  • the stent-graft 10 may be constructed with graft layers 18, 20 made from SIS material.
  • the SIS graft layers 18, 20 may be secured together with sutures, thermal bonding may also be used to avoid the introduction of foreign materials into the stent-graft 10. This may produce a stent-graft that is well-suited for replacement vessel applications, since the SIS material tends to become remodeled into the surrounding tissues after implantation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un ensemble endoprothèse (10) destiné à divers traitements médicaux. Cet ensemble endoprothèse comprend un stent (12) disposé entre une couche intérieure de matière de greffon (18) et une couche extérieure de matière de greffon (20). Les couches de greffon sont retenues fermement sur le stent par fixation des couches de greffon ensemble par l'intermédiaire d'ouvertures formées dans la structure du stent. Le mouvement relatif entre les couches de greffon et le stent est rendu possible par utilisation de marges libres entre les zones fixées des couches de greffon et les bords des ouvertures du stent.
PCT/US2005/009757 2004-03-31 2005-03-23 Endoprothese encapsulee avec fixation entre couches de greffon Ceased WO2005096998A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AT05729299T ATE464859T1 (de) 2004-03-31 2005-03-23 Eingekapselter stent graft mit verbindung zwischen den grafthüllen
AU2005231149A AU2005231149B2 (en) 2004-03-31 2005-03-23 Encapsulated stent-graft with graft to graft attachment
DE602005020760T DE602005020760D1 (de) 2004-03-31 2005-03-23 Eingekapselter stent graft mit verbindung zwischen den grafthüllen
CA2561498A CA2561498C (fr) 2004-03-31 2005-03-23 Endoprothese encapsulee avec fixation entre couches de greffon
EP05729299A EP1734899B1 (fr) 2004-03-31 2005-03-23 Endoprothese encapsulee avec fixation entre couches de greffon

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/815,105 US8034096B2 (en) 2004-03-31 2004-03-31 Stent-graft with graft to graft attachment
US10/815,105 2004-03-31

Publications (1)

Publication Number Publication Date
WO2005096998A1 true WO2005096998A1 (fr) 2005-10-20

Family

ID=34963467

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/009757 Ceased WO2005096998A1 (fr) 2004-03-31 2005-03-23 Endoprothese encapsulee avec fixation entre couches de greffon

Country Status (7)

Country Link
US (1) US8034096B2 (fr)
EP (1) EP1734899B1 (fr)
AT (1) ATE464859T1 (fr)
AU (1) AU2005231149B2 (fr)
CA (1) CA2561498C (fr)
DE (1) DE602005020760D1 (fr)
WO (1) WO2005096998A1 (fr)

Cited By (1)

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WO2022067413A1 (fr) * 2020-10-02 2022-04-07 Braile Biomédica Indústria Comércio E Representações Ltda. Agencement structural appliqué à une endoprothèse

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DE602005020760D1 (de) 2010-06-02
CA2561498C (fr) 2013-08-27
ATE464859T1 (de) 2010-05-15
EP1734899A1 (fr) 2006-12-27
AU2005231149A1 (en) 2005-10-20
US8034096B2 (en) 2011-10-11
EP1734899B1 (fr) 2010-04-21
US20050222667A1 (en) 2005-10-06
AU2005231149B2 (en) 2010-04-01

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